Persistence of Bactericidal Antibodies in Adults Who Received a Booster Dose of Menactra® Approximately 4 Years Earlier
NCT ID: NCT02633787
Last Updated: 2016-11-07
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
110 participants
INTERVENTIONAL
2015-12-31
2016-03-31
Brief Summary
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Objective:
* To evaluate the persistence of antibody responses (determined by a serum bactericidal assay using human complement (SBA-HC)) approximately 4 years after the administration of a booster dose of Menactra vaccine in trial MTA77
Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Study Group
Participants received a booster dose of Menactra vaccine approximately four years earlier
Meningococcal (Groups A, C, Y, and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine
No vaccine will be administered in this trial
Interventions
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Meningococcal (Groups A, C, Y, and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine
No vaccine will be administered in this trial
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Received booster dose of Menactra vaccine in trial MTA77
* Informed consent form has been signed and dated
* Able to attend the scheduled visit and to comply with all trial procedures.
Exclusion Criteria
* Receipt of any meningococcal vaccine, including serogroup B meningococcal vaccine, after receipt of the booster dose of Menactra vaccine administered in trial MTA77
* Receipt of immune globulins, blood or blood-derived products in the past 3 months
* Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
* History of meningococcal infection, confirmed either clinically, serologically, or microbiologically
* Bleeding disorder, thrombocytopenia, or receipt of anticoagulants contraindicating venipuncture at the discretion of the Investigator
* Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
* Current alcohol abuse or drug addiction
* Any illness that, in the opinion of the Investigator, might interfere with trial conduct or trial results
* Receipt of oral or injectable antibiotic therapy within 72 hours prior to the blood draw. (A prospective subject should not be included in the trial until 72 hours has passed.)
* Identified as an Investigator or employee of the Investigator or trial center with direct involvement in the proposed trial, or identified as an immediate family member (i.e., parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed trial.
18 Years
ALL
Yes
Sponsors
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Sanofi Pasteur, a Sanofi Company
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Sanofi Pasteur Inc.
Locations
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Bardstown, Kentucky, United States
Woburn, Massachusetts, United States
Niles, Michigan, United States
Layton, Utah, United States
Countries
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Related Links
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Related Info
Other Identifiers
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U1111-1161-3151
Identifier Type: OTHER
Identifier Source: secondary_id
MTA00093
Identifier Type: -
Identifier Source: org_study_id